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BRIEF TITLE: Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)

A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)


  • Org Study ID: D967VC00001
  • Secondary ID:
  • NCT ID: NCT04482309
  • NCT Alias:
  • Sponsor: AstraZeneca - Industry
  • Source: AstraZeneca

Brief Summary

This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors. This study will enroll 7 tumor-specific cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors. Study hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.

Overal Status Start Date Phase Study Type
Recruiting August 18, 2020 Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Objective Response Rate (ORR)

Primary Outcome 1 - Time Frame: An average of approximately 12 months

Condition:

  • Bladder Cancer, Biliary Tract Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Pancreatic Cancer, Rare Tumors

Eligibility

Criteria:
Inclusion Criteria:

- Locally advanced, unresectable, or metastatic disease based on most recent imaging.

- The respective cohorts for patient inclusion are:

- Cohort 1: Biliary tract cancer

- Cohort 2: Bladder cancer

- Cohort 3: Cervical cancer

- Cohort 4: Endometrial cancer

- Cohort 5: Epithelial ovarian cancer

- Cohort 6: Pancreatic cancer

- Cohort 7: Rare tumors: This cohort will consist of patients with tumors that
express HER2, excluding the tumors mentioned above, and breast, non-small cell
lung cancer, gastric cancer, and colorectal cancer.

- Progressed following prior treatment or who have no satisfactory alternative treatment
option.

- Prior HER2 targeting therapy is permitted.

- HER2 expression for eligibility may be based on local or central assessment.

- Has measurable target disease assessed by the Investigator based on RECIST version
1.1.

- Has protocol- defined adequate organ function including cardiac, renal and hepatic
function.

Exclusion Criteria:

- Uncontrolled intercurrent illness

- History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD that
cannot be ruled out by imaging at screening

- Lung-specific intercurrent clinically significant severe illnesses

- Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or
antifungals

- Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal
shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART

- Known Somatic DNA mutation of HER2 (ERBB2) without tumoral HER2 protein expression.

- Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or
rectum, adenocarcinoma of the gastric body or gastro-esophageal junction, or non-small
cell lung cancer.
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Gender: All

Minimum Age: 18 Years

Maximum Age: 120 Years

Healthy Volunteers: No

Overall Contact

Name: AstraZeneca Clinical Study Information Center

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

Locations

Facility Status Contact
Research Site
Houston, Texas 77030
United States
Not yet recruiting
Research Site
Seoul, 03080
Korea, Republic of
Not yet recruiting
Research Site
Seoul, 03722
Korea, Republic of
Not yet recruiting
Research Site
Taipei, 11217
Taiwan
Recruiting